Quality Professional

Abbott Laboratories; Northern (KY); Hybrid; USD 68,000 - 136,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO) next年

Tuition reimbursement

FreeU education benefit

Retirement plan with high employer贡献

Job summary

Abbott Laboratories in the United States is seeking a Quality Professional for the Transfusion Medicine division. You will analyze quality standards for components, materials, or services and apply measures, sampling methods, testing procedures to meet quality requirements.

Responsibilities include risk management, design verification/validation liaison, and ensuring documentation accuracy. Collaboration with cross-functional teams to maintain compliance with FDA, QSR, ISO guidelines.

Qualifications

• Bachelor’s degree in Life Science, Engineering, or closely related discipline is required.
• At least 3 years of work experience in Quality or related field.
• Knowledge of FDA, QSR, ISO guidelines and 21 CFR Part 11 is preferred.

Responsibilities

• Analyze quality standards for components, materials, or services.
• Apply testing methods and procedures to ensure quality standards.
• Review documentation for accuracy and compliance.
• Coordinate quality decisions with cross-functional teams.

Skills

Quality experience

Regulatory knowledge

Documentation skills

Education

Bachelor’s degree in Life Science or Engineering

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.Descritivo de Cargo**Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:* Career development with an international company where you can grow the career you dream of.* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.* An excellent retirement savings plan with a high employer contribution.* Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.* A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.* A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.**The Opportunity** This position works out of our **Abbott Park (Lake Bluff, IL)** location in the **Transfusion Medicine**, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.The **Quality Professional** will analyze quality standards for components, materials, or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.**What You’ll Work On*** Design/Change Control - Participating in the development & review of all design input, risk management, design verification, design validation, and design output/transfer related design change activity.* Risk Management – Understands and applies basic Risk Management principles. Participate in the development and/or modification of Risk Management Files, FMEA’s, etc.* Design Verification/Validation – Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records with a focus on assay and commodities.* Documentation - Reviews documentation for accuracy, clarity, consistency, completeness, and compliance for projects that vary from low to high complexity. Plans and perform assignments with a wide degree of difficulty.* Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance with site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.* Quality Engineering – May participate on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.* Apply quality principles, analyze quality records, prepare reports, and recommend improvements.* Conduct inspection, verification and validation of components or materials used in development processes.* Document quality issues and performance measures for management review.* May liaise with external vendors.**Required Qualifications*** Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.* At least 3 years' work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.* Demonstrate understanding of how their function supports the business.* Demonstrates technical and business competencies that drive results and continuous improvement.**Preferred Qualifications*** Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11**Apply Now****Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** https://abbottbenefits.com/Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.**The base pay for this position is**$68,000.00 – $136,000.00In specific locations, the pay range may vary from the range posted.Família de CargoOperations QualityDivisãoTM Transfusion MedicineLocalidadeUnited States > Abbott Park : AP20Localidades AdicionaisTurno de TrabalhoStandardViagemNoVigilância médicaNot ApplicableAtividades de trabalho significativasContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO\\_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO\\_Spanish.pdf